TEEClean® Automated TEE Probe Cleaner Disinfector | Automated Ultrasound Reprocessor

U.S. Patent No. 10,238,760

TEEClean Automated TEE Probe Cleaner Disinfector is the first product of its kind to be cleared by the US FDA. Designed exclusively for transesophageal echocardiogram ultrasound probes (TEE), TEEClean provides both manufacturers recommended cleaning and high-level disinfection of soiled TEE probes in the same device.

Current methods require manual cleaning to be completed so as to achieve proper high-level disinfection. TEEClean allows the healthcare professional to simply place a bedside cleaned TEE probe into the device, removing the potential of an ineffectively cleaned TEE probe being high-level disinfected.

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TEEClean is the first

Automated Ultrasound Reprocessor

cleared by the US FDA

TEEClean provides both a scientifically verified and repeatable method for cleaning soiled TEE probes. Incorporated in TEEClean is TEEZyme^®, an enzymatic solution that is injected into the cleaning and disinfection reservoir once a soiled TEE probe has been properly inserted. The TEEClean microprocessor controller then monitors all parameters of the cleaning step to ensure completion prior to high-level disinfection. After cleaning, TEEClean begins the validated and repeatable high-level disinfection process.

Features

Validated and FDA cleared cleaning method for TEE probes
Validated and FDA cleared high-level disinfection method for TEE probes
5-minute high-level disinfection of TEE probes
Automated enzymatic cleaning solution: TEEZyme
7" color touch screen display with vivid user icons for easy operation
Data entry with integrated barcode scanner or manual keyboard entry
Printed disinfection and maintenance record with integrated printer
Electronic record logging of all cleaning, disinfection and maintenance events for download, retention of over 15,000 records held in memory
5 nanometer filtered rinse water (.005 micron)- FDA cleared Class II medical device
Advanced vapor management system for containment of high-level disinfectant
Full system high-level disinfection for added preventative maintenance of TEEClean
CS Medical cleaner disinfector device validation process utilizes “worse-case” methodology, providing the margin of error necessary for real-world reprocessing

CS Medical has been our vendor for our TEE reprocessing for our TEE probes for greater than 5 years. They have consistently provided quality products that have ensured our compliance with HLD for this reusable medical devices. They have shown innovation in products that meet and exceed regulatory and best practice standards.

Betty M, Northside Hospital Atlanta

Benefits

Reduced Handling

TEEClean incorporates an FDA validated cleaning method and removes the labor and time intensive manual portion of this process. TEEClean automates the enzymatic soak that has traditionally occurred in a sink or basin. By removing the manual process, TEEClean significantly reduces the handling of the delicate transducer of the TEE probe thus further reducing the chance for damage. Cleaning is the most important element to the proper reprocessing of any reusable medical device. Without effective cleaning of the reusable medical device any disinfectant or sterilant cannot properly work.

Electronic Records

TEEClean provides electronic records retention of the clean and disinfection cycle and records device maintenance events. A printed record is provided with the built-in thermal printer

Simplified Workflow

To use TEEClean simply place the bedside enzymatically treated, soiled TEE Probe directly into TEEClean, no additional steps required. Then, by following simple prompts on the color LCD display, the healthcare professional will enter information about the probe, disinfectant chemistry used for high-level disinfection and if the probe passed electrical leakage testing.

FDA Cleared

TEEClean is designed to provide cleaning and high-level disinfection of transesophageal ultrasound probes. The system has been cleared for use with TD-5 and TD-8 high-level disinfectants. These products have been cleared under 510(k) number K182891.